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EC number: 237-551-3 | CAS number: 13837-60-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976-11-30 to 1977-01-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles with deviations: non-GLP study, no data about purity and no certificate of analysis of test substance; no information on the testing laboratory; individual irritation scores not reported
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Method: Draize Repeated Insult Patch test
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- 2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran
- EC Number:
- 237-551-3
- EC Name:
- 2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran
- Cas Number:
- 13837-60-0
- Molecular formula:
- C10H16O
- IUPAC Name:
- 2-ethynyl-2,6,6-trimethyloxane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2.0% Lyp or LYPTOL
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 60
- Number of subjects completed the study: 54
- Sex: 12 males; 42 females
- Age: 19-63 years
- Race: No data
- Demographic information: No data - Clinical history:
- - History of allergy or casuistics for study subject or populations: No person was accepted with active dermatologic conditions or other discernible illnesses.
- Medical history (for skin hypersensitivity): Previous sensitivities or history of allergy were noted but not considered to be reasons for rejection of volunteers. - Controls:
- No
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: Patch test (epicutaneous test)
PREPARATION OF THE SITE OF APPLICATION: Prior to the application, the application sites were cleansed vigorously with an ether-acetone mixture to remove any sebum or foreign material such as powders or bath oils while simultaneously mechanically removing layers of the protective keratotic outer-skin.
TESTING/SCORING SCHEDULE:
PILOT STUDY:
- Test material was applied under closed patches to the inner surface of the left deltoid area on a pilot group of ten subjects.
- When after 24 h of exposure there were no complaints of itching, burning or other paraesthesia, the patch tests were allowed to remain in situ for an additional 24 h, after which they were removed and the application sites were observed for dermal reactions.
MAIN STUDY:
A. INDUCTION EXPOSURE:
- Type of application: Occlusive
- No. of exposures: Ten
- Description of patch: Test material solution was applied to individual absorbent patches and then these patches were applied to the area of application. The patches were secured by means of overlying strips of impervious adhesive tape which were then further occluded with additional overlying strips of similar tape.
- Vehicle / solvent: Dimethyl phthalate
- Concentration: 2 %
- Volume applied: 0.5 cm3 (equivalent to 0.5 mL)
- Site: Applied alternatively on the inner surfaces of the right deltoid and the left deltoid areas
- Exposure period: 24 h for the first application and 48 or 72 h for the remaining applications (72 h on the weekends only)
B. CHALLENGE EXPOSURE:
- No. of exposures: Once in duplicate
- Day of challenge: Two weeks after the last application of the induction exposure
- Exposure period: 48 h
- Site: Applied on the inner surfaces of the right deltoid and the left deltoid areas
- Evaluation (h after removal of challenge patch): 0 h, 24 h and 5 days
Results and discussion
- Results of examinations:
- - No allergic reactions were noted.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test item, 2.0 % Lyp produced a 0% (0/54) sensitisation rate and was considered to be a nonsensitiser to human skin.
- Executive summary:
In a Draize Repeated Insult Patch Test, 60 human volunteers were topically induced with 0.5 mL of the test item, 2.0 % Lyp in dimethyl phthalate via occluded patches. The application was repeated ten times and the patches were applied alternatively on the inner surfaces of the right deltoid and the left deltoid areas. Exposure period was 24 h for the first application and 48 or 72 h for the remaining applications (72 h on the weekends only). After 2 weeks of rest period, duplicate challenge patches of the test material was applied to the right deltoid and the left deltoid areas for 48 h. Sensitisation reactions were recorded at 0 h, 24 h and 5 days after removal of the challenge patches.
Of the 60 volunteers, 54 completed the study. The test item produced no reaction in any of the volunteer.
Under the test conditions, the test item, 2.0 % Lyp produced a 0% (0/54) sensitisation rate and was considered to be a nonsensitiser to human skin.
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